IVDR Report Update 2024
After different delays and not without concerns, the implementation of IVDR, the new regulatory framework for in-vitro diagnostic in the EU, has now started. Molecular testing in oncology is likely to be one of the areas in which this legislation will have a bigger impact, with questions and concerns having been raised by all the stakeholders involved in biomarker testing. However, IVDR is here to stay, and laboratories are facing a transition period in which they will need to adapt to this new reality.
IVDR Update: 22NOV2024
Finally, Another Notified Body Announced.
Istituto Superiore di Sanita, based in Rome was announced as the 13th Notified Body (NB) in September, nearly a year after the previous new addition. ISS is the first NB in Italy. There are now 4 in Germany, 2 each in Finland and The Netherlands, and 1 each in Austria, France, Italy, Ireland and Slovakia. The low numbers of NB still represent a significant potential road block to the full implementation of IVDR yet, ironically, there are now reports that these NB may have spare capacity as manufacturers delay their applications in order to pursue regulatory submissions in other jurisdictions or wait to see what happens as a result of the extension to full implementation.
An Extension to the Extension
The European Commission has further extended the deadlines for full implementation of IVDR.As with the previous extension, the new one will be staggered according to device classification meaning implementation for Class A and B devices won’t occur until the end of the decade.
New dates are given in the table below.
EUDAMED: Mandatory Registration, At Least for Those Bits That Work
According to the European Commission: “EUDAMED is the IT system established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. EUDAMED is integral part of the implementation of the two Medical Devices Regulations.” It is structured around 6 modules and a public website but currently only 3 modules are available with the rest varying times away from deployment. The Commission has decided that IVD manufacturers will need to begin registration with those modules of EUDAMED that are deployed from Jan 2026 instead of waiting for the entire system to become available. Industry bodies have expressed concerns that manufacturers are not devoting sufficient resources to training users and preparing documentation for inclusion in EUDAMED and advise them to address registration on the system as soon as possible.
Included in mandatory notifications for manufacturers is a requirement for them to notify the EU or their Competent Authorities if an IVD is at risk of becoming unavailable.
Despite Progress and Extended Deadlines, There’s Still Concerns
Various groups have been expressing concerns about the slow implementation speed and complexity of both the MDR and IVDR.
A group of 29 national associations and the EU-wide industry association MedTech Europe sent an open letter to the Commission, via its outgoing Commissioner for Health & Food Safety, requesting action to ensure device availability and competitiveness. They also had this to say about the two regulations:
“The unpredictability, complexity, and burden of the regulations means that many devices on the market today as well as new, innovative medical technologies are not reaching patients in Europe as they should. The competitiveness of the wider industry and even the viability of many small businesses (SMEs) are at risk.”
They pointed out that the incoming regulatory process is complex, slow and overly bureaucratic, hampering companies who are trying to bring new products to market. This limits innovation and availability of cutting-edge products to EU patients, while reducing their competitiveness.
The industry associations also called for a series of bridging measures to “…halt the continued disappearance of devices from the EU market and for attracting investment in bringing innovations to Europe”
Industry isn’t the only group with concerns. Members of the European Parliament (MEPs) have also expressed their concerns about the medical device and IVD regulations. According one MEP, the EU “…has introduced "loads of rules" that do not increase safety, but cause expense and effort to rise and that costs us jobs and economic growth at a time when the European economy is in a crisis situation”, creating a “bureaucratic monster” in the process. The EU parliament called on the incoming Health Commissioner to “step up” the implementation of the current regulations and evaluate the need for potential changes otherwise MEPs agreed, MEPs agreed, Europe's (EU) competitiveness will further decline, industry will pay and patients will suffer further shortfalls in care.
Watch this space…